Methods and apparatus for deploying sheet-like materials

ABSTRACT

Implant delivery systems for delivering sheet-like implants include a delivery shaft, an implant expander, a sheath, and a sheet-like implant. In some embodiments, the delivery shaft has a proximal end and a distal end. The implant expander is mounted to the distal end of the delivery shaft. The implant expander includes a central portion and a plurality of leg portions radiating from the central portion. The implant expander is evertable between an unstressed configuration in which a distal surface of the implant expander defines a concave surface, and a first compact configuration in which the distal surface of the implant expander defines a convex surface. The implant expander has a first lateral extent when the implant expander is free to assume the unstressed configuration. The sheath defines a lumen having a lumen diameter. At least a portion of the delivery shaft is slidably disposed in the lumen. The lumen diameter is smaller than the first lateral extent of the implant expander so that the sheath holds the implant expander in the first compact configuration when slidably disposed therein. The sheet-like implant overlays at least a portion of the distal surface of the implant expander with portions of the sheet-like implant extending between the leg portions of the implant expander and the sheath. Methods of treating a rotator cuff of a shoulder are also disclosed.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/136,790 filed on Sep. 20, 2018, which is a continuation of U.S.application Ser. No. 14/883,105 filed on Oct. 14, 2015, which is acontinuation of U.S. application Ser. No. 12/794,673 filed on Jun. 4,2010, which claims benefit to U.S. Provisional Patent Application No.61/313,116, filed on Mar. 11, 2010 and U.S. Provisional PatentApplication No. 61/184,198, filed Jun. 4, 2009. The disclosures of eachof which are herein incorporated by reference in their entirety.

INCORPORATION BY REFERENCE

The present application is related to U.S. patent application Ser. No.12/794,540, U.S. Pat. No. 8,668,718, entitled Methods and Apparatus forFixing Sheet-like Materials to a Target Tissue, filed on Jun. 4, 2010;U.S. patent application Ser. No. 12/794,551, U.S. Pat. No. 8,821,536,entitled Methods and Apparatus for Delivering Staples to a TargetTissue, filed on Jun. 4, 2010; and, U.S. patent application Ser. No.12/794,677, U.S. Pat. No. 8,763,878, entitled Methods and ApparatusHaving a Bowstring-like Staple Delivery to a Target Tissue, filed onJun. 4, 2010, the disclosures of each incorporated herein by reference.

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIELD OF THE INVENTION

The present invention relates generally to orthopedic medicine andsurgery. More particularly, the present invention relates to methods andapparatus for delivery and fixation of medical devices, such as fortreating articulating joints.

BACKGROUND OF THE INVENTION

The glenohumeral joint of the shoulder is found where the head of thehumerus mates with a shallow depression in the scapula. This shallowdepression is known as the glenoid fossa. Six muscles extend between thehumerus and scapula and actuate the glenohumeral joint. These sixmuscles include the deltoid, the teres major, and the four rotator cuffmuscles. As disclosed by Ball et al. in U.S. Patent Publication No. U.S.2008/0188936 A1 and as illustrated in FIG. 1 the rotator cuff musclesare a complex of four muscles. These four muscles are the supraspinatus,the infraspinatus, the subscapularis, and the teres minor. The centeringand stabilizing roles played by the rotator cuff muscles are critical tothe proper function of the shoulder. The rotator cuff muscles provide awide variety of moments to rotate the humerus and to oppose unwantedcomponents of the deltoid and pectoralis muscle forces.

The four muscles of the rotator cuff arise from the scapula 12. Thedistal tendons of the rotator cuff muscles splay out and interdigitateto form a common continuous insertion on the humerus 14. Thesubscapularis 16 arises from the anterior aspect of the scapula 12 andattaches over much of the lesser tuberosity of the humerous. Thesupraspinatus muscle 18 arises from the supraspinatus fossa of theposterior scapula, passes beneath the acromion and the acromioclavicularjoint, and attaches to the superior aspect of the greater tuberosity 11.The infraspinatus muscle 13 arises from the infraspinous fossa of theposterior scapula and attaches to the posterolateral aspect of thegreater tuberosity 11. The teres minor 15 arises from the lower lateralaspect of the scapula 12 and attaches to the lower aspect of the greatertuberosity 11.

The mechanics of the rotator cuff muscles 10 are complex. The rotatorcuff muscles 10 rotate the humerus 14 with respect to the scapula 12,compress the humeral head 17 into the glenoid fossa providing a criticalstabilizing mechanism to the shoulder (known as concavity compression),and provide muscular balance. The supraspinatus and infraspinatusprovide 45 percent of abduction and 90 percent of external rotationstrength. The supraspinatus and deltoid muscles are equally responsiblefor producing torque about the shoulder joint in the functional planesof motion.

The rotator cuff muscles 10 are critical elements of this shouldermuscle balance equation. The human shoulder has no fixed axis. In aspecified position, activation of a muscle creates a unique set ofrotational moments. For example, the anterior deltoid can exert momentsin forward elevation, internal rotation, and cross-body movement. Ifforward elevation is to occur without rotation, the cross-body andinternal rotation moments of this muscle must be neutralized by othermuscles, such as the posterior deltoid and infraspinatus. The timing andmagnitude of these balancing muscle effects must be preciselycoordinated to avoid unwanted directions of humeral motion. Thus thesimplified view of muscles as isolated motors, or as members of forcecouples must give way to an understanding that all shoulder musclesfunction together in a precisely coordinated way—opposing musclescanceling out undesired elements leaving only the net torque necessaryto produce the desired action. Injury to any of these soft tissues cangreatly inhibit ranges and types of motion of the arm.

With its complexity, range of motion and extensive use, a fairly commonsoft tissue injury is damage to the rotator cuff or rotator cufftendons. Damage to the rotator cuff is a potentially serious medicalcondition that may occur during hyperextension, from an acute traumatictear or from overuse of the joint. With its critical role in abduction,rotational strength and torque production, the most common injuryassociated with the rotator cuff region is a strain or tear involvingthe supraspinatus tendon. A tear in the supraspinatus tendon 19 isschematically depicted in FIG. 2. A tear at the insertion site of thetendon with the humerus, may result in the detachment of the tendon fromthe bone. This detachment may be partial or full, depending upon theseverity of the injury. Additionally, the strain or tear can occurwithin the tendon itself. Injuries to the supraspinatus tendon 19 andrecognized modalities for treatment are defined by the type and degreeof tear. The first type of tear is a full thickness tear as alsodepicted in FIG. 2, which as the term indicates is a tear that extendsthrough the thickness of the supraspinatus tendon regardless of whetherit is completely torn laterally. The second type of tear is a partialthickness tear which is further classified based on how much of thethickness is torn, whether it is greater or less than 50% of thethickness.

The accepted treatment for a full thickness tear or a partial thicknesstear greater than 50% includes reconnecting the torn tendon via sutures.For the partial thickness tears greater than 50%, the tear is completedto a full thickness tear by cutting the tendon prior to reconnection. Incontrast to the treatment of a full thickness tear or a partialthickness tear of greater than 50%, the treatment for a partialthickness tear less than 50% usually involves physical cessation fromuse of the tendon, i.e., rest. Specific exercises can also be prescribedto strengthen and loosen the shoulder area. In many instances, theshoulder does not heal and the partial thickness tear can be the sourceof chronic pain and stiffness. Further, the pain and stiffness may causerestricted use of the limb which tends to result in further degenerationor atrophy in the shoulder. Surgical intervention may be required for apartial thickness tear of less than 50%, however, current treatmentinterventions do not include repair of the tendon, rather the surgicalprocedure is directed to arthroscopic removal of bone to relieve pointsof impingement or create a larger tunnel between the tendon and bonethat is believed to be causing tendon damage. As part of the treatment,degenerated tendon may also be removed using a debridement procedure inwhich tendon material is ablated. Again, the tendon partial tear is notrepaired. Several authors have reported satisfactory early postoperative results from these procedures, but over time recurrentsymptoms have been noted. In the event of recurrent symptoms, many timesa patient will “live with the pain”. This may result in less use of thearm and shoulder which further causes degeneration of the tendon and maylead to more extensive damage. A tendon repair would then need to bedone in a later procedure if the prescribed treatment for partial tearwas unsuccessful in relieving pain and stiffness or over time the tearpropagated through injury or degeneration to a full thickness tear or apartial thickness tear greater than 50% with attendant pain anddebilitation. A subsequent later procedure would include the moredrastic procedure of completing the tear to full thickness and suturingthe ends of the tendon back together. This procedure requires extensiverehabilitation, has relatively high failure rates and subjects thepatient who first presented and was treated with a partial thicknesstear less than 50% to a second surgical procedure.

As described above, adequate treatments do not currently exist forrepairing a partial thickness tear of less than 50% in the supraspinatustendon. Current procedures attempt to alleviate impingement or make roomfor movement of the tendon to prevent further damage and relievediscomfort but do not repair or strengthen the tendon. Use of the stilldamaged tendon can lead to further damage or injury. Prior damage mayresult in degeneration that requires a second more drastic procedure torepair the tendon. Further, if the prior procedure was only partiallysuccessful in relieving pain and discomfort, a response may be to usethe shoulder less which leads to degeneration and increased likelihoodof further injury along with the need for more drastic surgery. There isa large need for surgical techniques and systems to treat partialthickness tears of less than 50% and prevent future tendon damage bystrengthening or repairing the native tendon having the partialthickness tear.

SUMMARY OF THE INVENTION

According to aspects of the invention, implant delivery systems fordelivering sheet-like implants are disclosed. In some embodiments, theimplant delivery system includes a delivery shaft, an implant expander,a sheath, and a sheet-like implant. In these embodiments, the deliveryshaft has a proximal end and a distal end. The implant expander ismounted to the distal end of the delivery shaft. The implant expanderincludes a central portion and a plurality of leg portions radiatingfrom the central portion. The implant expander is evertable between anunstressed configuration in which a distal surface of the implantexpander defines a concave surface, and a first compact configuration inwhich the distal surface of the implant expander defines a convexsurface. The implant expander has a first lateral extent when theimplant expander is free to assume the unstressed configuration. Thesheath defines a lumen having a lumen diameter. At least a portion ofthe delivery shaft is slidably disposed in the lumen. The lumen diameteris smaller than the first lateral extent of the implant expander so thatthe sheath holds the implant expander in the first compact configurationwhen slidably disposed therein. The sheet-like implant overlays at leasta portion of the distal surface of the implant expander with portions ofthe sheet-like implant extending between the leg portions of the implantexpander and the sheath.

In some embodiments, a free end of each leg portion of the implantexpander is disposed distally of the central portion when the implantexpander is assuming the unstressed configuration. The free end of eachleg portion is disposed proximally of the central portion when theimplant expander is assuming the first compact configuration. Thedelivery shaft distal end may be fixed to the central portion of theimplant expander to urge relative movement between the implant expanderand the sheath such that the implant expander and the sheet-like implantcan be advanced through a distal opening defined by the sheath so theimplant expander is free to assume a deployed configuration.

In some embodiments, a projection extends distally from the distalsurface of the central portion of the implant expander to hold theposition of delivery system when the projection is held against a targettissue. The implant expander may generally conform to the surface of atarget tissue when the implant expander assumes the deployedconfiguration. In some embodiments, the distal surface of the implantexpander defines a concave surface when the implant expander is assumingthe deployed configuration and the target tissue has a generally convexshape. A free end of each leg portion may be disposed distally of thecentral portion when the implant expander is assuming the deployedconfiguration and the target tissue has a generally convex shape. Insome embodiments, the implant expander causes the sheet-like implant toconform to the surface of a target tissue when the implant expanderassumes the deployed configuration.

In some embodiments, the implant expander assumes a second compactconfiguration when the implant expander is retracted proximally into thelumen of the sheath after having assumed the deployed configuration. Thedistal surface of the implant expander may define a concave surface whenthe implant expander is assuming the second compact configuration. Insome embodiments, the free end of each leg portion is disposed distallyof the central portion when the implant expander is assuming the secondcompact configuration.

In some embodiments, the implant expander is integrally formed of asingle material. The sheet-like implant may define a plurality ofpockets. Each pocket may be dimensioned to receive a distal portion of aleg portion of the implant expander. In some of these embodiments, thesheet-like implant can be selectively separated from the implantexpander by withdrawing the distal portions of the legs from thepockets. In some embodiments, the implant expander further includes aplurality of retainers to engage the sheet-like implant such that thesheet-like implant moves when the implant expander is moved. In some ofthese embodiments, the sheet-like implant can be selectively separatedfrom the implant expander by withdrawing the retainers from thesheet-like implant.

According to aspects of the present invention, methods of treating arotator cuff of a shoulder are disclosed. In some embodiments, themethod includes the steps of providing an implant delivery system,inflating the shoulder to create a cavity therein, placing thesheet-like implant and the implant expander inside the cavity, allowingthe implant expander to assume a deployed configuration, attaching thesheet-like implant to the tendon, urging the implant expander to assumea second compact configuration, and removing the implant expander fromthe cavity. In these embodiments, the implant delivery system that isprovided includes an implant expander. The implant expander has acentral portion and a plurality of leg portions radiating from thecentral portion. The implant expander is evertable between an unstressedconfiguration in which a distal surface of the implant expander definesa concave surface, and a first compact configuration in which the distalsurface of the implant expander defines a convex surface. A sheet-likeimplant overlays at least a portion of the distal surface of the implantexpander. A sheath is disposed about the sheet-like implant and theimplant expander. The sheath holds the implant expander in the firstcompact configuration. When the sheet-like implant and the implantexpander are placed inside the cavity, a tendon is contacted with atleast a portion of the implant while the implant expander is assumingthe first compact configuration. When allowing the implant expander toassume a deployed configuration, the implant expander urges thesheet-like implant against a surface of the tendon. When urging theimplant expander to assume a second compact configuration, the distalsurface of the implant expander defines a concave surface.

In some embodiments, the implant expander includes a projectionextending distally from its central portion. The projection holds theposition of the delivery system relative to the tendon when thesheet-like implant and implant expander are placed in the cavity againstthe tendon.

In some embodiments, the step of allowing the implant expander to assumethe deployed configuration includes urging relative movement between theimplant expander and the sheath such that the implant expander and thesheet-like implant are advanced through a distal opening defined by thesheath. With this arrangement, the implant expander is free to assumethe deployed configuration. In some embodiments, urging relativemovement between the implant expander and the sheath includeswithdrawing the sheath in a proximal direction relative to the implantexpander. In some embodiments, urging relative movement between theimplant expander and the sheath includes advancing the implant expanderin a distal direction along the lumen of the sheath. In someembodiments, urging the implant expander to assume the second compactconfiguration includes advancing the sheath over the implant expander sothat the implant expander is disposed inside the lumen defined by thesheath. In some embodiments, urging the implant expander to assume thesecond compact configuration includes drawing the implant expanderproximally into the lumen defined by the sheath. In some embodiments,urging the implant expander to assume the second compact configurationincludes drawing the implant expander and the projection that extendsdistally from the central portion of the implant expander proximallyinto the lumen defined by the sheath.

According to aspects of the invention, methods of preparing a deliverysystem are disclosed. In some embodiments, these methods include thesteps of providing a delivery sheath and an implant expander, coveringat least a portion of the distal surface with a sheet-like implant, anddeflecting the implant expander. The sheath defines a lumen having alumen diameter. The implant expander includes a central portion and aplurality of leg portions radiating from the central portion. Theimplant expander is evertable between an unstressed configuration inwhich a distal surface of the implant expander defines a concavesurface, and a first compact configuration in which the distal surfaceof the implant expander defines a convex surface. The implant expanderhas a first lateral extent when the implant expander is free to assumethe unstressed configuration. The first lateral extent is greater thanthe lumen diameter of the sheath. When the implant expander isdeflected, the implant expander assumes the first compact configurationand the implant expander and the sheet-like implant are placed in thelumen defined by the sheath. The sheath holds the implant expander inthe first compact configuration with portions of the sheet-like implantbeing interposed between the leg portions of the implant expander and aninner surface of the sheath.

Further aspects of the present invention will become apparent uponreview of the Detailed Description with reference to the followingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a simplified perspective view of the human rotator cuff andassociated anatomical structure.

FIG. 2 is a schematic depiction of a full thickness tear in thesupraspinatus tendon of the rotator cuff of FIG. 1.

FIG. 3 is a stylized anterior view of a patient with a shoulder beingshown in cross-section for purposes of illustration.

FIG. 4 is a stylized anterior view of a shoulder including a humerus anda scapula. The head of the humerus is shown mating with the glenoidfossa of the scapula at a glenohumeral joint.

FIG. 5 is a stylized perspective view illustrating an exemplaryprocedure for treating a shoulder of a patient.

FIG. 6 is an enlarged perspective view further illustrating theprocedure shown in the previous Figure.

FIG. 7 is an enlarged perspective view showing the delivery system shownin the previous Figure.

FIG. 8 is a stylized perspective view of a shoulder including asupraspinatus muscle having a distal tendon.

FIG. 9 is an additional perspective view further illustrating a deliverysystem in accordance with this disclosure.

FIG. 10A through FIG. 10E are a series of stylized plan viewsillustrating an exemplary method in accordance with the present detaileddescription.

FIG. 11 is a stylized diagram illustrating four configurations of anexemplary implant expander.

FIG. 12 is a perspective view illustrating an exemplary delivery systemin accordance with this disclosure.

FIG. 13 is a plan view illustrating an exemplary assembly in accordancewith the present detailed description.

FIG. 14 is a plan view illustrating an exemplary assembly in accordancewith the present detailed description.

FIG. 15A through FIG. 15F are a series of stylized plan viewsillustrating exemplary methods and apparatus in accordance with thepresent detailed description.

FIG. 16 is a stylized depiction of a kit that may be used, for example,for delivering a sheet-like implant to a target location within the bodyof a patient.

FIG. 17A is an enlarged plan view illustrating a delivery aid includedin the kit of FIG. 16. FIG. 17B is a partial cross-sectional perspectiveview further illustrating the delivery aid shown in FIG. 17A.

FIG. 18A through FIG. 18I are a series of stylized plan viewsillustrating exemplary methods and apparatus in accordance with thepresent detailed description.

FIG. 19 is a plan view showing a locating guide included in the kit ofFIG. 16.

FIG. 20 is a plan view showing a locating guide removal tool included inthe kit of FIG. 16.

DETAILED DESCRIPTION OF THE INVENTION

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same. The drawings, which are not necessarily to scale, depictillustrative embodiments and are not intended to limit the scope of theinvention.

FIG. 3 is a stylized anterior view of a patient 20. For purposes ofillustration, a shoulder 22 of patient 20 is shown in cross-section inFIG. 3. Shoulder 22 includes a humerus 14 and a scapula 12. In FIG. 3, ahead 24 of humerus 14 can be seen mating with a glenoid fossa of scapula12 at a glenohumeral joint. With reference to FIG. 3, it will beappreciated that the glenoid fossa comprises a shallow depression inscapula 12. The movement of humerus 14 relative to scapula 12 iscontrolled by a number of muscles including: the deltoid, thesupraspinatus, the infraspinatus, the subscapularis, and the teresminor. For purposes of illustration, only the supraspinatus 26 is shownin FIG. 3.

With reference to FIG. 3, it will be appreciated that a distal tendon 28of the supraspinatus 26 meets humerus 14 at an insertion point. Scapula12 of shoulder 22 includes an acromium 32. In FIG. 3, a subacromialbursa 34 is shown extending between acromium 32 of scapula 12 and head24 of humerus 14. In FIG. 3, subacromial bursa 34 is shown overlayingsupraspinatus 26. Subacromial bursa 34 is one of the hundreds of bursaefound the human body. Each bursa comprises a fluid filled sac. Thepresence of these bursae in the body reduces friction between bodilytissues. Injury and/or infection of the bursa can cause it to becomeinflamed. This condition is sometimes referred to as bursitis.

The exemplary methods and apparatus described herein may be used to fixtendon repair implants to various target tissues. For example, a tendonrepair implant may be fixed to one or more tendons associated with anarticulating joint, such as the glenohumeral joint. The tendons to betreated may be torn, partially torn, have internal micro-tears, beuntorn, and/or be thinned due to age, injury or overuse. Applicantsbelieve that the methods and apparatus of the present application andrelated devices may provide very beneficial therapeutic effect on apatient experiencing joint pain believed to be caused by partialthickness tears and/or internal microtears. By applying a tendon repairimplant early before a full tear or other injury develops, the implantmay cause the tendon to thicken and/or at least partially repair itself,thereby avoiding more extensive joint damage, pain, and the need formore extensive joint repair surgery.

FIG. 4 is a stylized anterior view of a shoulder 22 including a humerus14 and a scapula 12. In FIG. 4, a head 24 of humerus 14 is shown matingwith a glenoid fossa of scapula 12 at a glenohumeral joint. Asupraspinatus 26 is also shown in FIG. 4. This muscle, along withothers, control the movement of humerus 14 relative to scapula 12. Adistal tendon 28 of supraspinatus 26 meets humerus 14 at an insertionpoint 30.

In the embodiment of FIG. 4, distal tendon 28 includes a first damagedportion 36. A number of loose tendon fibers 40 in first damaged portion36 are visible in FIG. 4. First damaged portion 36 includes a first tear42 extending partially through distal tendon 28. First tear 42 maytherefore be referred to as a partial thickness tear. With reference toFIG. 4, it will be appreciated that first tear 42 begins on the side ofdistal tendon 28 facing the subacromial bursa (shown in the previousFigure) and ends midway through distal tendon 28. Accordingly, firsttear 42 may be referred to as a bursal side tear.

With reference to FIG. 4, it will be appreciated that distal tendon 28includes a second damaged portion 38 located near insertion point 30. Inthe embodiment of FIG. 4, second damaged portion 38 of distal tendon 28has become frayed and a number of loose tendon fibers 40 are visible inFIG. 4. Second damaged portion 38 of distal tendon 28 includes secondtear 44. With reference to FIG. 4, it will be appreciated that secondtear 44 begins on the side of distal tendon 28 facing the humerus 14.Accordingly, second damaged portion 38 may be referred to as anarticular side tear.

In the embodiment of FIG. 4, a sheet-like implant 50 has been placedover the bursal side of distal tendon 28. With reference to FIG. 4, itwill be appreciated that sheet-like implant 50 extends over insertionpoint 30, first tear 42 and second tear 44. Some useful methods inaccordance with this detailed description may include placing a tendonrepair implant on the bursal side of a tendon regardless of whether thetears being treated are on the bursal side, articular side or within thetendon. In some cases the exact location and nature of the tears beingtreated may be unknown. A tendon repair implant may be applied to thebursal side of a tendon to treat shoulder pain that is most likelycaused by one or more partial thickness tears in the tendon. In theembodiment of FIG. 4, sheet-like implant 50 is fixed to distal tendon 28by a plurality of staples.

FIG. 5 is a stylized perspective view illustrating an exemplaryprocedure for treating a shoulder 22 of a patient 20. The procedureillustrated in FIG. 5 may include, for example, fixing tendon repairimplants to one or more tendons of shoulder 22. The tendons treated maybe torn, partially torn, have internal micro-tears, be untorn, and/or bethinned due to age, injury or overuse.

Shoulder 22 of FIG. 5 has been inflated to create a cavity therein. Inthe exemplary embodiment of FIG. 5, a fluid supply 52 is pumping acontinuous flow of saline into the cavity. This flow of saline exits thecavity via a fluid drain 54. A camera 56 provides images from inside thecavity. The images provided by camera 56 may be viewed on a display 58.

Camera 56 may be used to visually inspect the tendons of shoulder 22 fordamage. A tendon repair implant in accordance with this disclosure maybe fixed to a bursal surface of the tendon regardless of whether thereare visible signs of tendon damage. Applicants believe that the methodsand apparatus of the present application and related devices may providevery beneficial therapeutic effect on a patient experiencing joint painbelieved to be caused by internal microtears, but having no clear signsof tendon tears. By applying a tendon repair implant early before a fulltear or other injury develops, the implant may cause the tendon tothicken and/or at least partially repair itself, thereby avoiding moreextensive joint damage, pain, and the need for more extensive jointrepair surgery.

A delivery system 60 can be seen extending from shoulder 22 in FIG. 5.Delivery system 60 comprises a sheath that is fixed to a handle. Thesheath defines a lumen and a distal opening fluidly communicating withthe lumen. In the embodiment of FIG. 5, the distal opening of the sheathhas been placed in fluid communication with the cavity created inshoulder 22.

A tendon repair implant is at least partially disposed in the lumendefined by the sheath of delivery system 60. Delivery system 60 can beused to place the tendon repair implant inside shoulder 22. Deliverysystem 60 can also be used to hold the tendon repair implant against thetendon. In some embodiments, the tendon repair implant is folded into acompact configuration when inside the lumen of the sheath. When this isthe case, delivery system 60 may be used to unfold the tendon repairimplant into an expanded shape.

The tendon repair implant may be fixed to the tendon while it is heldagainst the tendon by delivery system 60. Various attachment elementsmay be used to fix the tendon repair implant to the tendon. Examples ofattachment elements that may be suitable in some applications includesutures, tissue anchors, bone anchors, and staples. In the exemplaryembodiment of FIG. 5, the shaft of a fixation tool 70 is shown extendinginto shoulder 22. In one exemplary embodiment, fixation tool 70 iscapable of fixing the tendon repair implant to the tendon with one ormore staples while the tendon repair implant is held against the tendonby delivery system 60.

FIG. 6 is an enlarged perspective view further illustrating theprocedure shown in the previous Figure. FIG. 6 also illustrates theinterior structure of shoulder 22 shown in the previous Figure. Withreference to FIG. 6, it will be appreciated that shoulder 22 includes ahumerus 14 and a scapula 12. In FIG. 6, a head 24 of humerus 14 is shownmating with a glenoid fossa of scapula 12 at a glenohumeral joint. Asupraspinatus 26 is also shown in FIG. 6. A distal tendon 28 ofsupraspinatus 26 can be seen meeting a tuberosity of humerus 14 in FIG.6.

Delivery system 60 is also shown in FIG. 6. In the embodiment of FIG. 6,a distal end of delivery system 60 has been positioned near distaltendon 28 of supraspinatus 26. Delivery system 60 comprises a sheath 102that is fixed to a handle 104. Sheath 102 defines a lumen 108 and adistal opening fluidly communicating with the lumen. In the embodimentof FIG. 6, a central portion of a sheet-like implant 50 can be seenextending through the distal opening defined by sheath 102. In theembodiment of FIG. 6, sheet-like implant 50 is overlaying an implantexpander. The implant expander and sheet-like implant 50 are bothassuming a compact configuration. The majority of sheet-like implant 50is disposed inside sheath 102. A central portion of sheet-like implant50 is extending out of sheath 102. This central portion of sheet-likeimplant 50 is contacting an outer surface of distal tendon 28 in theembodiment of FIG. 6.

FIG. 7 is an enlarged perspective view showing delivery system 60 shownin the previous Figure. In the embodiment of FIG. 7, sheath 102 ofdelivery system 60 has been moved in a proximal direction P relative tohandle 104. By comparing FIG. 7 to the previous Figure, it will beappreciated that sheet-like implant 50 and implant expander 120 are nowdisposed outside of lumen 108 defined by sheath 102. Implant expander120 comprises a central portion 122 and a plurality of leg portions 124radiating from central portion 122. In FIG. 7, leg portions 124 ofimplant expander 120 are shown overlaying sheet-like implant 50. Hub 126is shown overlaying central portion 122 of implant expander 120 in FIG.7. Implant expander 120 can be used to expand sheet-like implant 50 andhold sheet-like implant 50 against the surface of a target tissue.Sheet-like implant 50 may be fixed to the target tissue while theimplant is held against the target tissue by implant expander 120.

FIG. 8 is a stylized perspective view of a shoulder 22 including asupraspinatus 26 having a distal tendon 28. With reference to FIG. 8, itwill be appreciated that a tendon repair implant 50 has been fixed to asurface of distal tendon 28. Tendon repair implant 50 may comprise, forexample, various sheet-like structures without deviating from the spiritand scope of the present detailed description. In some usefulembodiments, the sheet-like structure may comprise a plurality offibers. The fibers may be interlinked with one another. When this is thecase, the sheet-like structure may comprise a plurality of aperturescomprising the interstitial spaces between fibers. Various processes maybe used to interlink the fibers with one another. Examples of processesthat may be suitable in some applications including weaving, knitting,and braiding. In some embodiment, the sheet-like structure may comprisea laminate including multiple layers of film with each layer of filmdefining a plurality of micro-machined or formed holes. The sheet-likestructure of the tendon repair implant may also comprise a plurality ofelectro-spun nanofiber filaments forming a composite sheet.Additionally, the sheet-like structure may comprise a synthetic spongematerial that defines a plurality of pores. The sheet-like structure mayalso comprise a reticulated foam material. Reticulated foam materialsthat may be suitable in some applications are available from BiomerixCorporation of Fremont, Calif. which identifies these materials usingthe trademark BIOMATERIAL™. The sheet-like structure may be circular,oval, oblong, square, rectangular, or other shape configured to suit thetarget anatomy.

Various attachment elements may be used to fix tendon repair implant 50to distal tendon 28 without deviating from the spirit and scope of thisdetailed description. Examples of attachment elements that may besuitable in some applications include sutures, tissue anchors, boneanchors, and staples. In the exemplary embodiment of FIG. 8, a pluralityof staples are fixing tendon repair implant 50 to distal tendon 28. Insome exemplary methods, a plurality of staples may be applied using afixation tool. The fixation tool may then be withdrawn from the body ofthe patient. Distal tendon 28 meets humerus 14 at an insertion point 30.With reference to FIG. 8, it will be appreciated that sheet-like implant50 extends over insertion point 30. Tendon repair implant may be appliedto distal tendon 28, for example, using the procedure illustrated in theprevious Figure. In various embodiments, staples may straddle theperimeter edge of the sheet-like implant (as shown in FIG. 8), may beapplied adjacent to the perimeter, and/or be applied to a central regionof the implant. In some embodiments, the staples may be used to attachthe implant to soft tissue and/or to bone.

FIG. 9 is an additional perspective view further illustrating deliverysystem 60. Delivery system 60 comprises a sheath 102 that is fixed to ahandle 104. Sheath 102 defines a lumen 108 and a distal opening 128fluidly communicating with lumen 108. In the embodiment of FIG. 9, adelivery aid 130 can be seen extending through distal opening 128defined by sheath 102.

In the embodiment of FIG. 9, delivery aid 130 comprises a hub 126 thatis disposed at the distal end of a control rod 132. An implant expander120 is attached to hub 126. Implant expander 120 comprises a centralportion 122 and a plurality of leg portions 124 radiating from centralportion 122. In FIG. 9, a sheet-like implant 50 is shown overlaying adistal surface of implant expander 120. In the exemplary embodiment ofFIG. 9, implant expander 120 is urging sheet-like implant 50 against agenerally spherical surface (not shown in FIG. 9).

Sheath 102 of delivery system 60 is coupled to a button 134. It will beappreciated that various other operative mechanisms may be used inaddition to button 134. Relative motion between button 134 and handle104 will cause similar relative motion between sheath 102 and handle104. In the exemplary embodiment of FIG. 9, sheath 102 will be moveddistally (relative to handle 104) when button 134 is moved distally(relative to handle 104). Additionally, sheath 102 will be movedproximally (relative to handle 104) when button 134 is moved proximally(relative to handle 104).

In FIG. 9, implant expander 120 is shown residing outside of lumen 108defined by sheath 102. In FIG. 9, implant expander 120 is shown assuminga deployed configuration. Implant expander 120 can be selectively urgedto assume a compact configuration, for example, by placing implantexpander inside lumen 108 defined by sheath 102. Implant expander can beplaced inside lumen 108, for example, by advancing sheath 102 overimplant expander 120.

FIG. 10A through FIG. 10E are a series of stylized plan viewsillustrating an exemplary method in accordance with the present detaileddescription. FIG. 10A through FIG. 10E may be referred to collectivelyas FIG. 10. A proximal direction is illustrated with an arrow P in FIG.10. A distal direction is illustrated with another arrow D in FIG. 10.The exemplary method of FIG. 10 may be used, for example, to fix asheet-like implant 50 to a surface 136 of a target tissue 138.

FIG. 10A is a partial cross-sectional view illustrating a distal portionof a delivery system 60 in accordance with this detailed description. Inthe embodiment of FIG. 10, the distal portion of delivery system 60 hasbeen positioned near a target tissue 138. Delivery system 60 comprises asheath 102 that is fixed to a handle. Sheath 102 defines a lumen 108 anda distal opening fluidly communicating with the lumen. In the embodimentof FIG. 10A, a central portion of a sheet-like implant 50 can be seenextending through the distal opening defined by sheath 102. In theembodiment of FIG. 10, sheet-like implant 50 is overlaying an implantexpander. The implant expander and sheet-like implant 50 are bothassuming a compact configuration. With reference to FIG. 10, it will beappreciated that the majority of sheet-like implant 50 is disposedinside sheath 102. A central portion of a sheet-like implant 50 isextending out of sheath 102.

Implant expander 120 of FIG. 10 comprises a central portion 122 and aplurality of leg portions 124 radiating from central portion 122. In theembodiment of FIG. 10A, implant expander 120 is assuming a first compactconfiguration. With reference to FIG. 10A, it will be appreciated thatthe free end of each leg portion 124 is disposed proximally of centralportion 122 when implant expander 120 is assuming the first compactconfiguration. With continuing reference to FIG. 10, it will beappreciated that a distal surface 140 of implant expander 120 defines aconvex surface when implant expander 120 is assuming the first compactconfiguration 142. Portions of sheet-like implant 50 can be seenextending between leg portions 124 of implant expander 120 and the wallof sheath 102. In FIG. 10, a fold 146 comprising a portion of sheet-likeimplant 50 can also be seen extending between an adjacent pair of legportions 124.

In the embodiment of FIG. 10B, a central portion of sheet-like implant50 is trapped between implant expander 120 and surface 136 of targettissue 138. By comparing FIG. 10A and FIG. 10B, it will be appreciatedthat sheet-like implant 50 has been advanced distally so that centralportion of sheet-like implant 50 is contacting surface 136 of targettissue 138.

In the embodiment of FIG. 10B, delivery system 60 includes a projection148 extending distally from distal surface 140 of central portion 122 ofimplant expander 120. In some applications, projection 148 may be usedto temporarily hold the position of delivery system 60 while sheet-likeimplant 50 is held against surface 136 of target tissue 138. In theexemplary embodiment of FIG. 10B, projection 148 comprises a spike 150having a generally cone-like shape. In the embodiment of FIG. 10B, spike150 has been advanced so that a distal portion of spike 150 has piercedtarget tissue 138. Spike 150 can be seen extending through sheet-likeimplant 50 in FIG. 10B. Spike 150 may be used to temporarily centerimplant expander 120 and sheet-like implant 50 on a target location.Once sheet-like implant 50 has been fixed to target tissue 138, spike150 can be withdrawn from target tissue 138 and sheet-like implant 50.

In FIG. 10C, implant expander 120 of delivery system 60 is shownassuming a deployed configuration. By comparing FIG. 10C and FIG. 10B,it will be appreciated that sheath 102 has been retracted in proximaldirection P. In the embodiment of FIG. 10C, leg portions 124 of implantexpander 120 are conforming to the shape of surface 136. In theexemplary embodiment of FIG. 10, surface 136 has a generally planarshape. Sheet-like implant 50 is resting between implant expander 120 andsurface 136 of target tissue 138, with sheet-like implant 50 overlayingsurface 136. With reference to FIG. 10C, it will be appreciated thatimplant expander 120 is causing sheet-like implant 50 to generallyconform to the shape of surface 136.

In FIG. 10D, implant expander 120 of delivery system 60 is shownassuming an unstressed configuration. By comparing FIG. 10C and FIG.10D, it will be appreciated that implant expander 120 has been lifted inproximal direction P. In the embodiment of FIG. 10D, no external forcesare acting on leg portions 124 and implant expander 120 is free toassume the unstressed configuration shown in FIG. 10D. With reference toFIG. 10D, it will be appreciated that the free end of each leg portion124 is disposed distally of central portion 122 when implant expander120 is assuming the unstressed configuration. With continuing referenceto FIG. 10, it will be appreciated that the distal surface 140 ofimplant expander 120 defines a concave surface when implant expander 120is assuming the unstressed configuration.

In FIG. 10E, implant expander 120 of delivery system 60 is shownassuming a second compact configuration. By comparing FIG. 10E and FIG.10D, it will be appreciated that implant expander 120 and sheath 102have been moved relative to each other. With reference to FIG. 10E, itwill be appreciated that implant expander 120 may be urged to assume thesecond compact configuration moving implant expander 120 and sheath 102relative to one another so that implant expander 120 is disposed inlumen 108 defined by sheath 102. With reference to FIG. 10, it will beappreciated that the free end of each leg portion 124 is disposeddistally of central portion 122 when implant expander 120 is assumingthe second compact configuration 144. With continuing reference to FIG.10, it will be appreciated that the distal surface 140 of implantexpander 120 defines a concave surface when implant expander 120 isassuming the second compact configuration 144.

FIG. 11 is a stylized diagram illustrating four configurations of anexemplary implant expander 120. The step of transitioning between oneconfiguration and another configuration is represented by three arrowsin FIG. 11. A proximal direction is illustrated with another arrow P inFIG. 11. A distal direction is illustrated with an additional arrow D inFIG. 11.

Implant expander 120 of FIG. 11 comprises a central portion 122 and aplurality of leg portions 124 radiating from central portion 122. Afirst arrow 1 represents a transition between a first compactconfiguration 142 and a deployed configuration 154. With reference toFIG. 11, it will be appreciated that the free end of each leg portion124 is disposed proximally of central portion 122 when implant expander120 is assuming the first compact configuration 142. With continuingreference to FIG. 11, it will be appreciated that a distal surface 140of implant expander 120 defines a convex surface when implant expander120 is assuming the first compact configuration 142. In some exemplarymethods, implant expander 120 is held in the first compact configuration142 while implant expander 120 is disposed in a lumen of a sheath. Inthese exemplary methods, implant expander 120 may be allowed to assumedeployed configuration 154 when the sheath is retracted from aroundimplant expander 120. Implant expander 120 may also be allowed to assumedeployed configuration 154 when implant expander 120 is moved in adistal direction so that implant expander 120 exits the lumen via adistal opening of the sheath or when the sheath moves proximally toreveal the implant expander from within the distal opening of the sheathand relieve stress within leg portions 124.

In the exemplary embodiment of FIG. 11, leg portions 124 of implantexpander 120 conform to the shape of a target tissue when implantexpander 120 is in the deployed configuration. In FIG. 11, implantexpander 120 is shown conforming to the shape of a generally planarsurface (not shown in FIG. 11) while implant expander is assuming thedeployed configuration. A second arrow 2 represents a transition betweenthe deployed configuration 154 and an unstressed configuration 152. Insome exemplary methods, implant expander 120 is free to assumeunstressed configuration 152 when implant expander 120 is lifted off ofa target surface so that no external forces are acting on leg portions124 of implant expander 120. With reference to FIG. 11, it will beappreciated that the free end of each leg portion 124 is disposeddistally of central portion 122 when implant expander 120 is assumingunstressed configuration 152. With continuing reference to FIG. 11, itwill be appreciated that the distal surface 140 of implant expander 120defines a concave surface when implant expander 120 is assuming theunstressed configuration 152.

A third arrow 3 represents a transition between the unstressedconfiguration 152 and a second compact configuration 144. In someexemplary methods, implant expander 120 is urged to assume secondcompact configuration 144 by drawing implant expander 120 proximallyinto a lumen of a sheath. With reference to FIG. 11, it will beappreciated that the free end of each leg portion 124 is disposeddistally of central portion 122 when implant expander 120 is assumingthe second compact configuration 144. With continuing reference to FIG.11, it will be appreciated that the distal surface 140 of implantexpander 120 defines a concave surface when implant expander 120 isassuming the second compact configuration 144.

FIG. 12 is a perspective view illustrating an exemplary delivery system360. Delivery system 360 comprises a sheath 302 that is fixed to ahandle 304. Sheath 302 defines a lumen 308 and a distal opening 328fluidly communicating with lumen 308. In the embodiment of FIG. 12, adelivery aid 330 can be seen extending through distal opening 328defined by sheath 302. In the embodiment of FIG. 12, delivery aid 330comprises a hub 326 that is disposed at the distal end of a control rod332. An implant expander 320 is attached to hub 326. Implant expander320 comprises a central portion 322 and a plurality of leg portions 324radiating from central portion 322.

Sheath 302 of delivery system 360 is coupled to an actuator 356.Relative motion between actuator 356 and handle 304 will cause similarrelative motion between sheath 302 and handle 304. In the exemplaryembodiment of FIG. 12, sheath 302 will be moved distally (relative tohandle 304) when actuator 356 is moved distally (relative to handle304). Additionally, sheath 302 will be moved proximally (relative tohandle 304) when actuator 356 is moved proximally (relative to handle304).

In FIG. 12, implant expander 320 is shown residing outside of lumen 308defined by sheath 302. I FIG. 12, implant expander 320 is shown assumingan unstressed configuration. Implant expander 320 can be selectivelyurged to assume a compact configuration, for example, by placing implantexpander inside lumen 308 defined by sheath 302. Implant expander can beplaced inside lumen 308, for example, by advancing sheath 302 overimplant expander 320.

FIG. 13 is a plan view illustrating an exemplary assembly in accordancewith the present detailed description. The assembly of FIG. 13 includesa sheet-like implant 50 and an implant expander 520. Implant expander520 of FIG. 13 comprises a central portion 522 and a plurality of legportions 524 radiating from central portion 522. In the embodiment ofFIG. 13, a sheet-like implant 50 is trapped between implant expander 520and a target tissue 538. With reference to FIG. 13, it will beappreciated that implant expander 520 includes a plurality of retainers558. In the embodiment of FIG. 13, retainers 558 engage sheet-likeimplant 50 so that sheet-like implant 50 moves when implant expander 520is moved and may aid in imparting lateral stress of the legs intolateral stress within the implant.

IG. 14 is a plan view illustrating an exemplary assembly in accordancewith the present detailed description. The assembly of FIG. 14 includesa sheet-like implant 50 and an implant expander 720. Implant expander720 of FIG. 14 comprises a central portion 722 and a plurality of legportions 724 radiating from central portion 722. In the embodiment ofFIG. 14, a sheet-like implant 50 is trapped between implant expander 720and a target tissue 738. With reference to FIG. 14, it will beappreciated that sheet-like implant 50 includes a plurality of pockets762. In the embodiment of FIG. 14, each pocket 762 is dimensioned toreceive the end of a leg portion 724 of implant expander 720. When thisis the case, implant expander 720 engages pockets 762 so that sheet-likeimplant 50 moves when implant expander 720 is moved.

FIG. 15A through FIG. 15F are a series of stylized plan viewsillustrating an exemplary method in accordance with the present detaileddescription. FIG. 15A through FIG. 15F may be referred to collectivelyas FIG. 15. A proximal direction is illustrated with an arrow P in FIG.15. A distal direction is illustrated with another arrow D in FIG. 15.The exemplary method of FIG. 15 may be used, for example, to fix asheet-like implant 50 to a surface of a target tissue 138.

FIG. 15A is a stylized plan view of illustrating a shoulder 22 of apatient. Shoulder 22 of FIG. 15A has been inflated to create a cavity 62therein. In the exemplary embodiment of FIG. 15A, a fluid supply 64 ispumping a continuous flow of saline into cavity 62. This flow of salineexits cavity 62 via a fluid drain 66.

In FIG. 15A, a sheath 102 of a delivery system 60 is shown positionednear a shoulder 22. Delivery system 60 also comprises a delivery aid 130including an implant expander that is fixed to the distal end of acontrol rod 132. In the embodiment of FIG. 15A, a sheet-like implant 50is overlaying the implant expander of delivery aid 130. In theembodiment of FIG. 15A, delivery aid 130 includes a projection 148extending distally from the implant expander. In the exemplaryembodiment of FIG. 15A, projection 148 comprises a spike 150 having agenerally cone-like shape. Spike 150 can be seen extending throughsheet-like implant 50 in FIG. 15A. Spike 150 may be used to temporarilycenter sheet-like implant 50 on a target location. Once sheet-likeimplant 50 has been fixed to target tissue 138, spike 150 can bewithdrawn from target tissue 138 and sheet-like implant 50.

Delivery aid 130 can be used to insert sheet-like implant 50 into cavity62 formed in shoulder 22. Delivery aid 130 can also be used to hold thesheet-like implant against a target tissue 138. In some embodiments, thesheet-like implant is folded into a compact configuration when insidethe lumen of the sheath. When this is the case, delivery aid 130 may beused to unfold the sheet-like implant into an expanded shape.

In FIG. 15B, sheath 102 is shown extending into shoulder 22. A distalopening of sheath 102 has been placed in fluid communication with cavity62 in the embodiment of FIG. 15B. By comparing FIG. 15A and FIG. 15B, itwill be appreciated that sheet like implant 50 has been advanceddistally so that a central portion of sheet like implant 50 iscontacting a surface of target tissue 138. The central portion of sheetlike implant 50 is trapped between implant expander 120 and the surfaceof target tissue 138 in the embodiment of FIG. 15B.

In FIG. 15C, implant expander 120 of delivery aid 130 is shown assuminga deployed configuration. By comparing FIG. 15C and FIG. 15B, it will beappreciated that sheath 102 has been retracted in a proximal directionP. Implant expander 120 of FIG. 15 comprises a central portion 122 and aplurality of leg portions 124 radiating from central portion 122. In theembodiment of FIG. 15B, implant expander 120 is assuming a deployedconfiguration. Implant expander 120 is fixed to the distal end ofcontrol rod 132 in the embodiment of FIG. 15.

Sheet like implant 50 is shown overlaying an outer surface of targettissue 138 in FIG. 15C. In the embodiment of FIG. 15C, sheet likeimplant 50 is generally conforming to the shape of target tissue 138.Implant expander 120 is holding sheet-like implant 50 against targettissue 138 in the embodiment of FIG. 15C.

Some exemplary methods in accordance with this detailed descriptioninclude the steps of inflating a shoulder to create a cavity therein andplacing a distal opening of a sheath in fluid communication with thecavity while the sheath is surrounding a delivery device disposed insidea lumen thereof and the sheath is maintaining the delivery device in afirst compact configuration. A central portion of the sheet-likematerial may be placed in contact with a surface of a target tissue. Thesheath may be withdrawn from around the delivery device so that thedelivery device is free to assume a deployed configuration inside thecavity. The delivery device may be used to hold the sheet-like materialagainst a surface of the target tissue while the delivery device isassuming the deployed configuration. The sheet-like implant 50 may befixed to the target tissue while sheet-like implant 50 is held againstthe surface of the target tissue. The delivery device may be urged toassume a second compact configuration as the delivery device is removedfrom the cavity.

In FIG. 15D, a fixation tool shaft 72 of a fixation tool 70 is shownextending into shoulder 22. In FIG. 15D, a distal end of fixation toolshaft 72 is disposed proximate an edge of sheet like implant 50. One ormore staples may be disposed inside fixation tool shaft 72. Fixationtool 70 may apply staples to fix sheet like implant 50 to target tissue138 while sheet like implant 50 is held in place by implant expander120.

Various attachment elements may be used to fix sheet like implant 50 totarget tissue 138 without deviating from the spirit and scope of thisdetailed description. Examples of attachment elements that may besuitable in some applications include sutures, tissue anchors, boneanchors, and staples. In the exemplary embodiment of FIG. 15E, sheetlike implant 50 is fixed to target tissue 138 by a plurality of staples74. In some exemplary methods, a plurality of staples may be appliedusing a fixation tool. The fixation tool may then be withdrawn from thebody of the patient. In the exemplary embodiment of FIG. 15E, deliveryaid 130 may be used to hold sheet like implant 50 against target tissue138 while staples 74 are applied using fixation tool 70.

With reference to FIG. 15F, it will be appreciated that delivery aid 130has been withdrawn from shoulder 22 and retracted into lumen 108 definedby sheath 102. Implant expander 120 of delivery aid 130 has been urgedto assume a second compact configuration in the embodiment of FIG. 15F.Implant expander 120 comprises a central portion 122 and a plurality ofleg portions 124 radiating from central portion 122. With reference toFIG. 15F, it will be appreciated that the free end of each leg portionis disposed distally of central portion 122 when implant expander 120 isassuming the second compact configuration.

FIG. 16 is a stylized depiction of a kit 123. In the exemplaryembodiment of FIG. 16, kit 123 comprises a sheet-like implant 50 and anumber of tools that may be used in conjunction with sheet-like implant50. The tools of kit 123 may be used, for example, for deliveringsheet-like implant 50 to a target location within the body of a patient.These tools may also be used, for example, for fixing sheet-like implant50 to a target tissue.

In the exemplary embodiment of FIG. 16, kit 123 comprises a locatingguide 125, a locating guide removal tool 127, a fixation tool 70, and adelivery aid 129. In some useful embodiments, locating guide 125includes a temporary fixation mechanism proximate its distal end. Amethod in accordance with the present detailed description may includetemporarily fixing the distal end of locating guide 125 to a targettissue and advancing sheet-like implant 50 over locating guide 125 fordelivering the sheet-like implant to the target location. In someapplications, delivery aid 129 may be used for advancing sheet-likeimplant 50 over locating guide 125 and urging sheet-like implant 50against a target tissue. Fixation tool 70 of kit 123 may be used, forexample, for fixing sheet-like implant 50 to the target tissue. Locatingguide removal tool 127 may be used to remove locating guide 125 aftersheet-like implant 50 has been fixed to the target tissue. In theembodiment of FIG. 16, fixation tool 70 includes a fixation tool shaft72.

FIG. 17A is an enlarged plan view illustrating delivery aid 129 shown inthe previous Figure. FIG. 17B is a partial cross-sectional perspectiveview further illustrating delivery aid 129. FIG. 17A and FIG. 17B may becollectively referred to as FIG. 17. A distal direction is illustratedwith an arrow D in FIG. 17.

In the exemplary embodiment of FIG. 17, delivery aid 129 includes animplant expander 133 fixed to a distal end of a control rod 135. Implantexpander 133 of FIG. 17 has a central portion 137 and an outer portion139 extending radially from central portion 137. In the embodiment ofFIG. 17, no external forces are acting on implant expander 133 andimplant expander 133 is free to assume an unstressed configuration. Withreference to FIG. 17B, it will be appreciated that a distal surface 143of implant expander 133 comprises a generally concave surface 145 whenthe implant expander is assuming an unstressed configuration. Withcontinuing reference to FIG. 17, it will be appreciated that anoutermost edge 147 of outer portion 139 is disposed distally of centralportion 137 when implant expander 133 is assuming the unstressedconfiguration.

FIG. 18A through FIG. 18I are a series of stylized plan viewsillustrating an exemplary method in accordance with the present detaileddescription. FIG. 18A through FIG. 18I may be referred to collectivelyas FIG. 18. A proximal direction is illustrated with an arrow P in FIG.18. A distal direction is illustrated with another arrow D in FIG. 18.The exemplary method of FIG. 18 may be used, for example, to fix asheet-like implant 50 to a surface of a target tissue 138.

In FIG. 18A, a cannula 149 is shown extending into a shoulder 22.Cannula 149 defines a lumen 153. A distal end of cannula 149 is locatedproximate a target tissue 138. The distal end of cannula 149 defines adistal opening that fluidly communicates with lumen 153.

In FIG. 18B, a locating guide 125 is shown extending through lumen 153defined by cannula 149. Some methods in accordance with the presentdisclosure may include the step of advancing the distal end of alocating guide through a cannula. In the embodiment of FIG. 18B, adistal portion of locating guide 125 is disposed in target tissue 138.In some useful embodiments, the distal portion of locating guide 125includes a barb. When this is the case, the barb may help maintain theposition of the distal end of locating guide 125 in the target tissue

In FIG. 18C, a sheet-like implant 50 is shown disposed about locatingguide 125. Some methods in accordance with the present disclosure mayinclude the step of inserting a locating guide through a sheet-likeimplant. Some of these methods may also include the step of advancingthe sheet-like implant over the locating guide toward a target tissue.

In FIG. 18D, a delivery aid 129 is shown disposed about locating guide125. Some methods in accordance with the present disclosure may includethe step of inserting the proximal end of a locating guide 125 into adistal aperture of a delivery aid 129. When this is the case, thedelivery aid 129 may be advanced over locating guide 125 for urging asheet-like implant 50 toward a target tissue (e.g., target tissue 138).In this way, delivery aid 129 may be used to urge sheet-like implant 50in a longitudinal direction along locating guide 125. In someapplications, delivery aid 129 may also be used to hold sheet-likeimplant 50 against a target tissue.

In the embodiment of FIG. 18E, sheet-like implant 50 is disposed in alumen 153 defined by cannula 149. By comparing FIG. 18E and FIG. 18D, itwill be appreciated that sheet-like implant 50 has been pushed distallyinto lumen 153. In the embodiment of FIG. 18E, sheet-like implant 50 hasbeen folded into a compact configuration. Sheet-like implant 50 is shownoverlaying the implant expander of delivery aid 129 in FIG. 18E. In theexemplary embodiment of FIG. 18E, the implant expander is urged toassume a first compact configuration as the implant expander andsheet-like implant 50 are advanced into lumen 153.

In the exemplary embodiment of FIG. 18F, sheet-like implant 50 is shownoverlaying target tissue 138. Some methods in accordance with thepresent detailed description include the step of passing a sheet-likeimplant through a cannula. In the exemplary embodiment of FIG. 18F, forexample, sheet-like implant 50 may be pushed through cannula 149 usingdelivery aid 129. Delivery aid 129 may also be used to hold sheet-likeimplant 50 against target tissue 138 while a surgeon attaches sheet-likeimplant 50 to target tissue 138.

In FIG. 18G, a fixation tool shaft 72 of a fixation tool 70 is shownextending through cannula 149. In FIG. 18G, a distal end of fixationtool shaft 72 is disposed proximate sheet-like implant 50. One or morestaples may be disposed inside fixation tool shaft 72. Some methods inaccordance with the present detailed description include the step ofpassing a staple through a cannula. In the exemplary embodiment of FIG.18G, for example, a staple may be passed through cannula 149 while thestaple resides in fixation tool shaft 72.

In the exemplary embodiment of FIG. 18H, sheet-like implant 50 is fixedto target tissue 138 by a plurality of staples 74. In some exemplarymethods, a plurality of staples may be applied to a sheet-like implantand a target tissue using a fixation tool. The fixation tool may then bewithdrawn from the body of the patient. With reference to FIG. 18H, itwill be appreciated that delivery aid 129 has been withdrawn fromshoulder 22 and locating guide 125 remains in the position shown in FIG.18H.

In the exemplary embodiment of FIG. 18I, locating guide 125 has beenwithdrawn from shoulder 22. Some useful methods in accordance with thepresent detailed description, include the use of a locating guideincluding a temporary fixation mechanism located proximate its distalend. These exemplary methods may also include the use of a locatingguide removal tool to aid in withdrawing the locating guide from thebody of the patient. In FIG. 18I, a plurality of staples 74 can be seenfixing sheet-like implant 50 to target tissue 138.

FIG. 19 is a plan view showing a locating guide 125. With reference toFIG. 19, it will be appreciated that locating guide 125 has a point 155at its distal end. In the embodiment of FIG. 19, locating guide 125includes a barb 157 near its distal end. In FIG. 19, point 155 is shownpointing in a distal direction D and barb 157 is shown pointing in aproximal direction P.

FIG. 20 is a plan view showing a locating guide removal tool 127.Locating guide removal tool 27 may be used, for example, to remove alocating guide 125 from a target tissue. In the embodiment of FIG. 20,locating guide removal tool 127 includes a tubular body 159 that isfixed to a grip 163. In operation, tubular body 159 is advanced over theproximal end of a locating guide so that a portion of the locating guideextends into a lumen defined by tubular body 159. Locating guide removaltool 127 may then be used to grasp a proximal portion of the locatingguide and produce relative motion between the locating guide and tubularbody 159.

In the embodiment of FIG. 20, a lever 165 is pivotably coupled to grip163. Relative motion between locating guide 125 and tubular body 159 canbe produced by rotating lever 165 relative to grip 163 when locatingguide removal tool 127 is grasping the proximal portion of locatingguide 125. This relative motion can be used to advance tubular body 159over the barb 157 of locating guide 125. Locating guide 125 may bewithdrawn from the body of the patient while tubular body 159 iscovering barb 157.

While exemplary embodiments of the present invention have been shown anddescribed, modifications may be made, and it is therefore intended inthe appended claims and subsequently filed claims to cover all suchchanges and modifications which fall within the true spirit and scope ofthe invention.

What is claimed is:
 1. An implant delivery system adapted to deliver asheet-like implant, the implant delivery system comprising: a deliveryshaft extending along a longitudinal axis, the delivery shaft includinga proximal end and a distal end; an implant expander including aplurality of flexible legs and a hub portion coupled to the distal endof the delivery shaft, wherein the plurality of flexible legs areconfigured to move between a compact configuration and an expandedconfiguration; a projection extending distally from the hub portion ofthe implant expander along the longitudinal axis; and a sheet-likeimplant; wherein the plurality of flexible legs are positioned along asurface of the sheet-like implant in the expanded configuration; whereinthe projection comprises a pointed distal tip pointing in a distaldirection along the longitudinal axis, the pointed distal tippenetrating through the sheet-like implant in the expanded configurationto pierce tissue.
 2. The implant delivery system of claim 1, whereinportions of the sheet-like implant extend between the plurality offlexible legs of the implant expander in the expanded configuration. 3.The implant delivery system of claim 1, wherein the sheet-like implantis secured to free ends of the plurality of flexible legs.
 4. Theimplant delivery system of claim 3, wherein the plurality of flexiblelegs are elastically deformed in the compact configuration.
 5. Theimplant delivery system of claim 1, wherein the plurality of flexiblelegs are elastically deformed in the compact configuration.
 6. Theimplant delivery system of claim 5, wherein a lower surface of theimplant expander defines a concave surface in the expandedconfiguration.
 7. The implant delivery system of claim 1, furthercomprising a sheath, wherein the delivery shaft is slidably disposed inthe lumen of the sheath.
 8. The implant delivery system of claim 7,wherein the implant expander is constrained within the lumen of thesheath in the compact configuration.
 9. The implant delivery system ofclaim 8, wherein the implant expander assumes the expanded configurationwhen the implant expander is positioned distal of the sheath.
 10. Animplant delivery system adapted to deliver a sheet-like implant, theimplant delivery system comprising: a delivery shaft extending along alongitudinal axis, the delivery shaft including a proximal end and adistal end; an implant expander including a plurality of flexible legsand a hub portion coupled to the distal end of the delivery shaft,wherein the plurality of flexible legs are configured to move between acompact configuration and an expanded configuration; a projectionextending distally from the hub portion of the implant expander alongthe longitudinal axis; and a sheet-like implant having an upper surfaceand a lower surface; wherein the plurality of flexible legs arepositioned along the upper surface of the sheet-like implant in theexpanded configuration; wherein the projection comprises a pointeddistal tip pointing in a distal direction along the longitudinal axis,the pointed distal tip penetrating through the sheet-like implant fromthe upper surface to the lower surface in the expanded configuration topierce tissue.
 11. The implant delivery system of claim 10, wherein thesheet-like implant is secured to free ends of the plurality of flexiblelegs.
 12. The implant delivery system of claim 10, wherein the pluralityof flexible legs are elastically deformed in the compact configuration.13. The implant delivery system of claim 12, wherein a lower surface ofthe implant expander defines a concave surface in the expandedconfiguration.
 14. The implant delivery system of claim 10, furthercomprising a sheath, wherein the delivery shaft is slidably disposed inthe lumen of the sheath.
 15. The implant delivery system of claim 14,wherein the implant expander is constrained within the lumen of thesheath in the compact configuration.
 16. The implant delivery system ofclaim 15, wherein the implant expander assumes the expandedconfiguration when the implant expander is positioned distal of thesheath.
 17. A method of deploying a sheet-like implant comprising:positioning an implant delivery device proximate a target tissue site,the implant delivery device comprising: a delivery shaft having aproximal end and a distal end; an implant expander coupled to the distalend of the delivery shaft via a hub portion of the implant expander, theimplant expander including a plurality of flexible legs; a projectionextending distally from the implant expander through a sheet-likeimplant disposed along the plurality of flexible legs; and pressing adistal tip of the projection against a target tissue causing the distaltip to penetrate into the target tissue while the projection reversiblypenetrates through the sheet-like implant; attaching the sheet-likeimplant to the target tissue; and thereafter, withdrawing the projectionfrom the sheet-like implant.
 18. The method of claim 17, wherein theplurality of flexible legs press the sheet-like implant against thetarget tissue during the attaching step.
 19. The method of claim 18,wherein the sheet-like implant is secured to free ends of the pluralityof flexible legs during the attaching step.
 20. The method of claim 19,wherein the free ends of the plurality of flexible legs are releasedfrom the sheet-like implant during the withdrawing step.